I. INTRODUCTION

Recently, international trade agreements have introduced big changes, not only in the area of trade, but, via the Agreement on Trade-Related Aspects of Intellectual Property Rights (or the TRIPs Agreement), also in the area of intellectual property. These are changes in what constitutes intellectual property and in where this is defined: important decisions are being removed from the national level to the global level. As a result, even the stakeholders are changing, and public health officials have to become involved in discussions on intellectual property rights, notably patents.

Before looking at the (technical) issues in greater detail, it is important to mention that the patent system is not without problems. In fact, developing countries have been requested to apply or expand the patent system at a moment when there is growing concern, even in developed countries, about the impact of this system on innovation and on investment. So developing countries have been requested to implement a system that has some important flaws and that is increasingly criticized:

“The relentless march of intellectual property rights needs to be stopped and questioned. Developments in the new technologies are running far ahead of the ethical, legal, regulatory and policy frameworks needed to govern their use. More understanding is needed - in every country - of the economic and social consequences of the TRIPs Agreement. Many people have started to question the relationship between knowledge ownership and innovation. Alternative approaches to innovation, based on sharing, open access and communal innovation, are flourishing, disproving the claim that innovation necessarily requires patents.”

UNDP Human Development Report 1999

“The global regime of intellectual property rights requires a new look. The United States prevailed upon the world to toughen patent codes and cut down on intellectual piracy. But now transnational corporations and rich-country institutions are patenting everything from the human genome to rainforest biodiversity. The poor will be ripped off unless some sense and equity are introduced into this runaway process.”

Jeffrey Sachs, The Economist, 14 August 1999

Developing countries should actively participate in a process of rethinking the intellectual property rights system, in terms of its impact on innovation and in terms of North-South relationship.

Furthermore, legislators in developing countries should realize that the TRIPs Agreement is not a uniform law, but that it leaves room for manoeuvre, albeit within certain limits. Countries can use this room to design legislation which is adequate and in the best interest of the country. Measures to protect public health or the public interest can be included in the national legislation. In order to do this, cooperation among the Ministry of Health, the Ministry of Trade and the Patent Office is of utmost importance.

TRIPs begins, in its very first Article, with the statement that, while countries may provide for higher levels of protection (compared to the TRIPs standards), they shall not be obligated or required to do so. Moreover, the Article continues that countries themselves shall determine how to implement the different requirements through their own domestic laws; this means that countries cannot be required to follow exactly the example of other countries - even though at times there is pressure to do so.